Urine Meter Foley Tray with Temperature Sensor

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K903816 ↗

FDA Product Code

EZK

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SEKD

• Bi-Temp Temperature Monitor, Model TM-300D

  Class II

  FDA 510(k) K913082 Active Cleared 11 Dec 1991

• Endotracheal Tube Guide or Intubation Stylette

  Class II

  FDA 510(k) K854632 Active Cleared 3 Jan 1986

• Esophageal Stethoscope W/Thermocouple Type T

  Class II

  FDA 510(k) K864043 Active Cleared 15 Dec 1986

• Bi-Temp Temperature Monitor, Model Tm-400D

  Class II

  FDA 510(k) K912280 Active Cleared 17 Oct 1991

• Adap-Temp Temperature Sensor Adapter

  Class II

  FDA 510(k) K921190 Active Cleared 9 Mar 1993

• Myocardinal Temperature Sensor with Type 400 Serie

  Class II

  FDA 510(k) K920469 Active Cleared 11 Sep 1992

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